The Indian Council of Medical Research (ICMR) has come up with the ‘operational guidelines for single ethics review of multicentre research’ to replace the existing common and joint ethics review mechanisms followed by clinical trial regulators in the country. The move is expected to strengthen and harmonise ethical review mechanisms for multicentre research studies nationwide.

“Through these operational guidelines for single ethics review, India affirms its commitment to delivering research that is scientifically robust, ethically sound and responsive to national priorities”, says Rajiv Bahl, director general of ICMR. “By streamlining processes, this initiative positions India to deliver what is required for its people evidence based solutions that improve health, strengthen public trust, and contribute meaningfully to national development”, he adds.

The single ethics review process simplifies the ethics review of multicentre research by delegating  the responsibility to undertake ethics review to a single ethics committee located at one mutually agreed upon study coordinating site from amongst all the participating sites. Settings without formal institutional structures such as field sites, community based locations or outreach centres can thus become part of clinical trials due to this mechanism.

In their preface to the “Operational Guidelines for Single Ethics Review of Multicentre Research in India,” Gitanjali Batmanabane, chairperson, ICMR Expert Advisory Committee and Roli Mathur, Head, ICMR Bioethics Unit stated that the model seeks to minimise unnecessary duplication while preserving institutional responsibilities for local implementation, monitoring and contextual safeguards. “The success of this framework rests fundamentally on trust in institutional competence, mutual cooperation among participating investigators and ethics committees, and transparent continuous communication throughout the research cycle”, they said.

The guidelines cover multicentre research coordination, scientific review, identification and review process of single ethics committee, review of informed consent process, site-specific considerations etc.

“The guideline is intended to serve as a reference for researchers and ethics committees not only in India but also to be widely consulted internationally, providing an implementable system that minimises delays and redundancies while upholding  the highest standards of participant protection”, Batmanabane and Mathur said.